How to Reconcile Powder Recovery Efficiency and Regulatory Compliance?

5 March, 2025 | ChargePoint Technology

Recent pharmaceutical breakthroughs, particularly in cell and gene therapies (C&GTs), mAb therapies, and advanced therapy medicinal products (ATMPs), have significantly improved patient outcomes.

However, the high costs associated with developing and manufacturing these innovative treatments limit their accessibility.

To address this issue, the industry must focus on increasing production efficiency through process intensification.

One of the most effective ways to achieve this is by improving the recovery of powdered active pharmaceutical ingredients (APIs) and other crucial materials used in drug production, ultimately leading to higher product yields and reduced costs. At the same time, pharmaceutical companies need to ensure that all of their processes follow rigorous regulatory requirements to support patient and worker safety.

In this blog, we will explore the challenges associated with increasing powdered product recovery, while also ensuring the highest levels of regulatory compliance.

The challenge of minimising waste during powder handling

Single-use technology (SUT) bags are essential tools in powder handling for the efficient and safe transfer of powdered APIs and other materials within production processes.

A key challenge is maximizing powder recovery from these bags to enhance production efficiency and minimize waste. While many SUT bags are designed for maximum yield, their effectiveness is influenced by factors like crevices and indents.

Optimal bag design is crucial for improving powder recovery. Features such as a funnel shape with a minimum 45-degree angle, seamless joints, and welded components can significantly enhance powder flow and minimize residual product.

Liquid rinsing of SUT bags, facilitated by a fully welded liquid entry connection, can be a highly effective method for ensuring complete product recovery. However, it is essential to consider the compatibility of the bag material with the chosen liquid, as well as potential extractables and process compatibility.

Regulatory considerations

Production line efficiency through powder recovery must be taken into account alongside adherence to stringent regulatory requirements. The latest revisions to Annex 1 of the Good Manufacturing Practice (GMP) guidelines highlight this balance, emphasizing strict protocols for sterile drug manufacturing.

These guidelines now explicitly recognize the advantages of single-use equipment, such as SUT bags.

A core component of these updated guidelines is the mandate for a comprehensive contamination control strategy. This strategy must encompass the design, operation, and maintenance of cleanroom facilities, as well as rigorous equipment protocols and personnel training. The ultimate goal is to ensure a high degree of assurance in eliminating contamination within the final drug product.

To comply with Annex 1, the use of SUT bags and any related powder recovery processes must be incorporated into the overall contamination control strategy. The bags must be manufactured in an appropriate controlled environment and gamma irradiated to guarantee sterility before use. Additionally, SUT bags must be designed to meet biocompatibility and cytotoxicity standards.

Solving the puzzle with expert support

Finding a way to achieve both optimum regulatory compliance and manufacturing efficiency in powder transfer processes can be complex and daunting for pharmaceutical companies. Seeking answers to these challenges from powder transfer specialists – especially those with experience in SUT equipment – can help manufacturers achieve both goals effectively.

The key questions that pharmaceutical companies need to ask of powder transfer specialists to ensure that their SUT bags and other manufacturing processes support maximum yield recovery and regulatory compliance can be found in our eBook: Powderful Impact: An engineer’s guide to solving the containment conundrum with single-use technology.

ChargePoint’s global experts are also here to answer any questions – get in touch today.

How to Reconcile Powder Recovery Efficiency and Regulatory Compliance?

The challenge of minimising waste during powder handling

Regulatory considerations

Solving the puzzle with expert support

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